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Found 10863 cases where Vaccine is PNC13

Case Details (Reverse Sorted by Appearance Date)

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VAERS ID:535576 (history)  Vaccinated:2014-05-23
Age:0.3  Onset:2014-06-05, Days after vaccination: 13
Gender:Female  Submitted:2014-07-01, Days after onset: 26
Location:Foreign  Entered:2014-07-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Malt extract; Lact. acid-producing orgs; Bisacodyl; Hydrocortisone butyrate; Zinc oxide; Temafloxacin HCl
Current Illness: Constipation; Eczema
Preexisting Conditions: Conjunctivitis
Diagnostic Lab Data: Ultrasound scan, 05Jun2014, target sign in s; Ultrasound scan, 06Jun2014, target sign disa
CDC Split Type: B1003740A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURJ1712 SCUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH12J02A SCUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA823AA PO 
Administered by: Other     Purchased by: Other
Symptoms: Crying, Haematochezia, Intussusception, Soft tissue mass, Ultrasound scan abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad)
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 14-week-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included constipation. Concurrent medication included Hib (non-gsk); non-GSK manufacturer; subcutaneous; unknown given on 23 May 2014; Pneumo vaccines (non-gsk); non-GSK manufacturer; subcutaneous; unknown given on 23 May 2014. Concurrent medications included Malt extract, BIOFERMIN and TELEMINSOFT. On 23 May 2014, the subject received an unspecified dose of ROTARIX (1.5 ml, oral). On 5 June 2014, 13 days after vaccination with ROTARIX, the subject experienced bloody stools. At the time of examination, the subject was in a good mood. The subject drank breast milk normally and had no vomiting. The bowel sound was good with soft abdomen, and no other findings except for the bloody stool were observed. The subject''s mother mentioned that the subject sometimes cried suddenly. The physician considered the events medically significant (or requiring intervention). The subject was taken to Medical Center B on referral. Ultrasonography was performed at the outpatient department, and showed a target sign in the small intestine. However, since the subject''s condition was stable, it was decided to place the subject under observation without any treatment. The mother was advised to take the subject to the medical center immediately if any problem occurred, and the subject was sent home. On 06 June 2014, the subject was taken to Medical Center B without any symptoms. Ultrasonography was performed again at the outpatient department, and the target sign was revealed to have disappeared. The subject had no symptoms suggestive of invagination of intestine other than the bloody stool. While the target sign was observed, the sign could develop with conditions other than invagination of intestine, definitive diagnosis could not be made. It was difficult to assess whether the event was merely bloody stool or invagination of intestine. Although invagination of intestine was suspected, evidence was scarce to make definitive diagnosis. At the time of reporting, the events were improved. The physician considered invagination of intestine and bloody stools were related to vaccination with ROTARIX. Follow-up information received on 23 June 2014: The subject''s medical history included conjunctivitis. No previous intra-abdominal surgery, no congenital intestinal malformation, no intestinal polyp, no Meckel''s diverticulum, no intestinal vascular malformations, no cystic fibrosis, no Hirschsprung disease, no other gastrointestinal malformation and dysfunction, nor intussusception. There was no family history of intussusception or bowel abnormalities. Concurrent medical conditions included constipation and eczema. Concurrent medications included LOCOID, SATOSALBE and OZEX. On 30 May 2014, the subject was taken to the hospital again for constipation tendency that the subject had originally presented with and left eye discharge (conjunctivitis). OZEX ophthalmic solution was prescribed. On 05 June 2014, at 9 am, the subject had no bowel movement since 01 June 2014, and TELEMINSOFT suppository 2 mg was used. At 11 am, the subject defecated a large amount of stools twice, in which a small amount of bloody stool was noted. No change was noted in the milk intake. The subject had no vomiting and was in a normal mood. At 2.30 pm, obvious bloody stool was noted, and the subject was taken to Hospital A with her nappy. No abnormalities were noted on examination. Around 5 pm, the subject was taken to the department of pediatrics at Medical Center B. No abnormalities were noted by upright chest and abdominal radiography, but a target sign suggestive of intussusception was noted by abdominal echography. No clinical symptoms were noted nonetheless. No plain abdominal radiograph showing a visible intussusception or soft tissue mass was performed, neither plain abdominal radiograph

VAERS ID:535578 (history)  Vaccinated:2011-07-21
Age:0.2  Onset:2013-10-01, Days after vaccination: 803
Gender:Female  Submitted:2014-06-27, Days after onset: 269
Location:Foreign  Entered:2014-07-01, Days after submission: 4
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: 02-NOV-2013, Activated partial thromboplastin time, 46.5 seconds; 11-NOV-2013, Activated partial thromboplastin time, 54.8 seconds, 12-NOV-2013, Activated partial thromboplastin time, 50.1 seconds; 15-NOV-2013, Activated partial thromboplastin time, 50.1 seconds; 25-NOV-2013, Activated partial thromboplastin time, 40.4 seconds; 04-NOV-2013, Alanine aminotransferase, 43 IU/l; 25-NOV-2013, Alanine aminotransferase, 37 IU/l; 11-NOV-2013, Antibody test, Pneum IgG positive; 02-NOV-2013, Aspartate aminotransferase, 62 IU/l; 04-NOV-2013, Aspartate aminotransferase, 21 IU/l; 11-NOV-2013, Aspartate aminotransferase, 55 IU/l; 02-NOV-2013, Band neutrophil count, 20%; Base excess, -4.3 mmol/l; 02-NOV-2013, Blood albumin, 10.7 g/l; 11-NOV-2013, Blood al
CDC Split Type: 2014169503
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF190470IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activated partial thromboplastin time prolonged, Alanine aminotransferase increased, Antibody test positive, Apparent life threatening event, Aspartate aminotransferase increased, Atelectasis, Band neutrophil percentage increased, Base excess negative, Blood albumin decreased, Blood bicarbonate decreased, Blood calcium decreased, Blood chloride normal, Blood cholesterol decreased, Blood creatinine decreased, Blood fibrinogen increased, Blood galactose, Blood glucose normal, Blood group O, Blood lactate dehydrogenase increased, Blood methaemoglobin, Blood potassium increased, Blood sodium decreased, Blood triglycerides normal, Bronchiectasis, C-reactive protein increased, Carboxyhaemoglobin normal, Chest X-ray abnormal, Computerised tomogram abnormal, Computerised tomogram head abnormal, Drug eruption, Ear infection, Ear tube insertion, Eosinophil percentage decreased, Fungal test positive, Gamma-glutamyltransferase increased, General physical health deterioration, Haematocrit decreased, Haemoglobin decreased, Hyponatraemia, Immunology test abnormal, Interleukin level increased, Lipase normal, Lobar pneumonia, Lung infiltration, Lymph node palpable, Lymphocyte percentage decreased, Mechanical ventilation, Metamyelocyte percentage, Monocyte percentage increased, Mononuclear cell percentage, Myelocyte percentage, Neutrophil count decreased, PCO2 decreased, PO2 decreased, Platelet count increased, Pleural fluid analysis, Pneumococcal infection, Pneumonia, Pneumonia necrotising, Pneumothorax, Protein total decreased, Pseudomonas test positive, Purulent discharge, Red blood cell count decreased, Respiratory failure, Rhesus antibodies positive, Staphylococcus test positive, Streptococcus test positive, Tachypnoea, Thoracic cavity drainage, Upper respiratory tract infection, Vaccination failure, White blood cell count decreased, White blood cell count increased, pH body fluid normal
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Haemolytic disorders (narrow), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Dyslipidaemia (narrow), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Lack of efficacy/effect (narrow), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hearing impairment (broad), Vasculitis (broad), Neonatal disorders (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad)
Write-up: This is a spontaneous report received from the Health Authority. Regulatory Authority report number DE-PEI-PEI2014041855. A contactable physician reported that a 28-month-old female patient of unknown ethnicity received first dose of PREVENAR 13 (lot number F19047) on 21Jul2011, second dose (lot number F22809) on 18 Aug2011, third dose (lot number F32047) on 15Sep2011 and fourth dose (lot number F63697) on 13Sep2012, all at 0.5 ml single dose of via intramuscular route. First, second and third dose had been tolerated. In Oct2013 after vaccination the patient developed atelectasis, hyponatremia, otitis, pneumothorax, respiratory failure, vaccination failure, pleuropneumonia and pneumococcal infection. Differentia-diagnosis: immunodeficiency was excluded. The patient was hospitalized and condition was life threatening. Diagnosis was confirmed by Pneumococcal test positive (Serotype 3). Results of tests and procedures relevant to the investigation of the patient: Pneumococcal test positive. No causality assessment was provided. The patient recovered from pleuropneumonia after 8 weeks on an unspecified date in 2013. The patient recovered from the events, but it was not known if the patient suffered from a permanent damage. Clinical course was as follows: the patient was hospitalized from 02Nov2013 until 30Nov2013. Diagnosis was necrotizing pleuropneumonia (thorax drainage on 02Nov2013); pneumococcal infection, otitis purulent left and right (cramming drainage on 11Nov2013), respiratory insufficiency, lung atelectasis, pneumothorax right, hyponatremia, drug exanthema (suspicion of drug intolerance against meropenem) and withdrawal symptomatology. Anamnesis: the patient presented 8 days infection of the upper respiratory tract, treated by the pediatrician with Ibuprofen and Prospan. On 02Nov2013 she went to hospital due to otitis purulent. Patient was admitted to hospital with tachypnea and there a radiological examination was done. A total shadowing was diagnosed and the patient was moved to another hospital. Patient had an inconspicuous vaccination status (received pneumococcal vaccination for 4 times). The patient was from Mar2013 until Jun2013. State at admission: general condition reduced, limp, pale skin, no exanthema. Pulmonary examination showed breath noise greatly attenuated: pure, rhythmic, reddened throat, tonsil bland, cervical lymph nodes palpable, abdomen soft, heart rate 155/in, blood pressure 106/78 mmHg, temperature 38.3 C. Microbiological investigation of pleural exudate (02Nov2013): streptococcus pneumoniae, serotype 3. Therapy and course: Immediate surgical preparation, then a pleural drainage system right was performed. Treatment included postoperative mechanical ventilation, monitoring, infusion of glucose-electrolyte-solution, antibiotic therapy with ampicillin and clindamycin, sedation with Esketamin, Fentanyl and Midazolam, stress-ulcers-prophylaxis with Pantoprazol and synchronized Intermittent mandatory ventilation O2 saturation). Antibiotic therapy was switched to Meropenem on 07Nov2013. On 09Nov2013 extension to Tobramycin (administered until 14Nov2013) and Fosfomycin. Due to ongoing otitis (with leaking of purulent secretion out of the ear left), tube insertion was performed on 11Nov2013 in both sides. Extubation was on 15Nov2014 and usage of an high-flow-O2-mask. Due to withdrawal, symptomatic administered of Clonidin, phenobarbital and Levomepromazin was performed. Removal of the pleuradrainage on 19Nov2013. Little later, signs of pneumothorax right were noted and drainage was reopened. Renewed attempt for drainage removal on 22Nov2013, but again pneumothorax right and reopening. Central-venous-catheter removal on 22Nov2013 and stop of the high-flow-O2 ventilation (spontaneously breathing sufficient). Stop of the treatment with Meropenem on 26Nov2013, Fosfomycin on 27Nov2013, and switch to ampicillin/sulbactam oral. Meropenem associated drug exanthem occurred, a further treatment was possible under

VAERS ID:535579 (history)  Vaccinated:2014-05-01
Age:0.4  Onset:0000-00-00
Gender:Male  Submitted:2014-06-30
Location:Foreign  Entered:2014-07-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Past drug event, CINQUERIX; PREVENAR 13
Diagnostic Lab Data:
CDC Split Type: 2014172905
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEUR  UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Ear pain, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Malaise, Oropharyngeal pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This is a spontaneous report received from a consumer (patient''s mother) via the regulatory agency. Regulatory authority number GB-MHRA-ADR 22576099. A 20-week-old male patient of an unknown ethnicity received on 01May2014 PREVENAR 13 (reported as 20 weeks injection), on the right leg and PEDIACEL (reported as 16 weeks injection) on the left leg, both via an unknown route of administration. The patient''s medical history and concomitant medications were not reported. The patient previously took two doses of PEDIACEL and a dose of PREVENAR 13 on an unknown dates. On an unknown date, the patient experienced injection site swelling, injection site redness, injection site pain (described as "swollen redness" on both legs and very sore). The patient also experienced sore throat, ear pain, sickness, flu like symptoms and fever. The patient wouldn''t settle in the day or night. The mother stated that she had never seen a reaction like that before and that it was quite scary. She rang a doctor, who said it was normal. The mother took the patient to see a doctor six days after the injections as it was still bad. The symptoms and swelling passed a few days later. The events recovered on an unknown date. The reporter considered the case to be serious as the events were medically significant and the regulatory authority considered the case to be serious for an unspecified reason. No follow-up attempts possible. No further information expected.

VAERS ID:535580 (history)  Vaccinated:2014-05-23
Age:0.3  Onset:2014-05-23, Days after vaccination: 0
Gender:Male  Submitted:2014-06-30, Days after onset: 38
Location:Foreign  Entered:2014-07-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Infantile spitting up; Observation in hospital: the child had excessive swallowing thought to be caused by spitting up
Diagnostic Lab Data: 25-MAY-2014, C-reactive protein, Normal; 25-MAY-2014, White blood cell count, 11.2
CDC Split Type: 2014175585
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA20CB045B0UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG792970UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Apnoea, C-reactive protein normal, Depressed level of consciousness, Fatigue, Hypersomnia, Hypotonia, Listless, Pallor, Staring, White blood cell count normal
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number NO-NOMAADVRE-FHI-2014-17697. A 3-month-old male patient received first dose PREVENAR 13 (lot number G79297), parenteral, on 23May2014, at 0.5 ml single, and first dose INFANRIX-IPV/Hib (lot number A20CB045B), parenteral, on 23May2014, at 1 DF single. Medical history included infantile spitting up: observation in hospital: the child had excessive swallowing thought to be caused by spitting up. The patient''s concomitant medications were not reported. The patient slept a lot on 23May2014 with outcome of recovered. On 25May2014 the patient experienced depressed level of consciousness, had listlessness, pallor, had hypotonia, had two short episodes with apnoea lasting a few seconds and slept more after the vaccination. He was still excessively tired. During the short apnea, the child level of consciousness seemed decreased. His eyes partially closed and when stimulated he had a staring gaze and seemed not able to give contact, before he breathed normally and gave normal contact again. The patient was hospitalized for a day and night for observation for all the reported events, except for tiredness, considered non-serious by the reporter. He had tiredness also after he was discharged from the hospital. The patient recovered from all the reported events. The patient underwent lab tests and procedures which included C-reactive protein: normal on 25May2014, white blood cell count: 11.2 on 25May2014. The action taken in response to the events to PREVENAR 13 was not applicable, for PEDIACEL was not applicable. The events are not a contra-indication for further use of the same vaccine or other vaccines and should not alter the child''s future vaccination program. The regulatory agency assessed the causality between all the events and both the suspect products as possibly related. No follow-up attempts possible. No further information expected.

VAERS ID:535581 (history)  Vaccinated:2014-04-16
Age:0.3  Onset:2014-04-17, Days after vaccination: 1
Gender:Male  Submitted:2014-06-30, Days after onset: 74
Location:Foreign  Entered:2014-07-01, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 2014-04-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: 16-APR-2014, Body temperature, 36.8 Centigrade
CDC Split Type: 2014173735
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPIPV: DTP + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER4K05C1SCUN
HIBV: HIB (ACTHIB)SANOFI PASTEURJ16711SCUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH13E03A1SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cardiac massage, Cardio-respiratory arrest, Death, Pallor, Peripheral coldness, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This is a spontaneous report received from a contactable prescribed pediatrician and a contactable treatment pediatrician through Ministry of Health, Labor and Welfare (MHLW) under the regulatory authority report number of V14000161. A 4-month-old male patient of an unspecified ethnicity (birth weight: 3360 g) received the 2nd dose of PREVENAR 13 (Lot # 13E03A), via subcutaneous route, on 18Apr2014; the 2nd dose of ACT-HIB (Lot # J1671), via subcutaneous route, on 16Apr2014, and the first dose of DIPHTHERIA TOX/PERTUSSIS VACC/POLIOMYELITIS VACCINE INACT/TETANUS TOX (Lot # 4K05C), vis subcutaneous route, on 16Apr2014. Body temperature before vaccination was 36.8 degrees C. The patient did not have underlying disease, complication, medical history, allergy, history of adverse drug reaction and concomitant drugs. The patient did not receive any vaccination in the past 1 month. The patient experienced cardio-respiratory arrest at 05:47 am on 17Apr2014. Clinical course was as follows. On 17Apr2014: The patient slept in a supine position after being breast-feeding at 03:00 am. As the patient was sleeping in a prone position when the mother of the patient noticed, the mother put the patient in a supine position (the patient just became to do roll-over recently). Thereafter the mother fell asleep. The patient was sleeping in a prone position again when the mother noticed. Thus the mother tried to change the patient''s position, and then she realized that the patient''s lip turned to pale and legs were cold. An ambulance was called and cardiac massage was performed. The patient presented with cardio-respiratory arrest when he arrived at the reporter''s hospital. The patient did not response to resuscitation and death of the patient was confirmed. The pediatrician classified the event as serious (death) and assessed the causality as unevaluable while mentioning a possibility of asphyxiation due to prone position.

VAERS ID:535225 (history)  Vaccinated:2014-06-24
Age:1.0  Onset:2014-06-24, Days after vaccination: 0
Gender:Male  Submitted:2014-06-24, Days after onset: 0
Location:New York  Entered:2014-06-30, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy, Amoxicillin (rash)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUH967AA3IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.J0058460SCLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH065683IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0091670SCRL
Administered by: Public     Purchased by: Unknown
Symptoms: Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Patient in for well child check, given 4 vaccines as ordered, parent in agreement. Parent and child leave facility go to birthday party and baby has some frosting and starts vomiting, that when mom notices rash on trunk and face. Return to clinic.

VAERS ID:535230 (history)  Vaccinated:2014-04-18
Age:1.0  Onset:2014-04-26, Days after vaccination: 8
Gender:Female  Submitted:2014-06-30, Days after onset: 65
Location:Michigan  Entered:2014-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.J0090100UNLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH828AA3UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.J0085330UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH080913UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0085210UNRL
Administered by: Private     Purchased by: Private
Symptoms: Varicella post vaccine
SMQs:
Write-up: Child felt to have contacted chickenpox 1 week after receiving varicella vaccine.

VAERS ID:535255 (history)  Vaccinated:2014-06-27
Age:1.0  Onset:2014-06-27, Days after vaccination: 0
Gender:Female  Submitted:2014-06-30, Days after onset: 3
Location:North Carolina  Entered:2014-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS4H9R40IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.J0061370SCLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH080923IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0111240SCLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Within 8 hours, rash started on legs (left), spread onto diaper region and then up trunk on to face. Resolved within 48 hours.

VAERS ID:535256 (history)  Vaccinated:2014-06-20
Age:10.0  Onset:2014-06-21, Days after vaccination: 1
Gender:Male  Submitted:2014-06-24, Days after onset: 3
Location:Texas  Entered:2014-06-30, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Benzoyl peroxide; Bisacodyl; Calcium carb; Carbidopa-Levodopa; Cerovite; Clonidine; Florastor; Gabapentin; Hydrocortisone; Levetiracetam; Magnesium oxide; Melatonin; Montelukast; Pantoprazole; Phenobarbital; Sorbitol; Topiramate; vitamin D3
Current Illness: None
Preexisting Conditions: Severe head injury as a result of motor vehicle accident of 8/12/2011, resulting in significant brain injury; Evacuation of left subdural hematoma with bone flap 8/12/2001; Laparoscopic gastrostomy placement and tracheotomy 8/27/2011; Replacement of bone flap autograft cranioplasty 9/21/2011; Left frontal bur hole with evacuation of epidural fluid 9/28/2011; Bronchoscopy for decannulation 10/6/2011; Seizure disorder, onset 12/2011, characterized by myoclonic jerking and extremities become tonic with head and eye aversion to the right, also with lip smacking and staring which may last anywhere from 45 seconds to 90 seconds and these began to occur on a daily basis in 12/2012; Abnormal EEG 2/1/2013 showing multifocal independent spike wave di
Diagnostic Lab Data: 6/21 WBC = 12.5, bands = 11; BUN = 3; UA = positive for ketones, protein (30), specific gravity = 1.3015; X-ray showed elevation of right hemi-diaphragm and bilateral consolidation
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 0IMUN
Administered by: Other     Purchased by: Public
Symptoms: Band neutrophil count increased, Blood urea decreased, Diarrhoea, Grunting, Haematochezia, Specific gravity urine increased, Urine ketone body present, White blood cell count increased, X-ray abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)
Write-up: Grunting with respirations, respiratory rate 44, heart rate 138, one bloody stool. CBC, CMP, UA and x-ray reported below. Patient showed clinical improvement by 5:50pm. Reported labs the next morning were normal and lungs sounded clear. That day (22nd) the patient had multiple loose stools without abdominal tenderness or distension, and he was given PEDIALYTE. Complete recovery in 24 hours with no intervention.

VAERS ID:535373 (history)  Vaccinated:2014-06-11
Age:0.5  Onset:0000-00-00
Gender:Male  Submitted:2014-06-30
Location:Florida  Entered:2014-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ranitidine hydrochloride
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, Jun2014, 40Deg. C
CDC Split Type: A1078043A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSKN2FL SYRUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH47689 SYRUN
Administered by: Private     Purchased by: Private
Symptoms: Irritability, Opisthotonus, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of arching back in a 6-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PREVENAR. Concurrent medications included Ranitidine and ZANTAC. On 11 June 2014, the subject received unspecified dose of PEDIARIX (unknown route and injection site), unspecified dose of PREVENAR (unknown route and injection site). In June 2014, less than one week after vaccination with PEDIARIX and PREVENAR, the subject experienced arching back, irritability and fever (40 Deg. C). On 12 June 2014 in the morning, the subject was brought back into the doctor''s office and from there was taken by ambulance to the emergency room. The reporter thought the subject was not admitted to the hospital but she did not see any further information in the chart to indicate that. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. After these events, pertussis vaccination was added as a possible allergy to subject''s chart.

VAERS ID:535383 (history)  Vaccinated:2014-04-25
Age:0.3  Onset:2014-05-14, Days after vaccination: 19
Gender:Male  Submitted:2014-06-30, Days after onset: 47
Location:Ohio  Entered:2014-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: METROHEALTHESP20126800
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSE4T92   
HIBV: HIB (ACTHIB)SANOFI PASTEURUH973AB   
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG98915   
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.J007436   
Administered by: Private     Purchased by: Unknown
Symptoms: Serum sickness
SMQs:, Hypersensitivity (narrow)
Write-up: Ot serum react d/t vacc on 2014-05-14.

VAERS ID:535391 (history)  Vaccinated:2014-06-12
Age:1.1  Onset:2014-06-13, Days after vaccination: 1
Gender:Male  Submitted:2014-06-30, Days after onset: 17
Location:Michigan  Entered:2014-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multi Vitamin with Iron Liquid 1 time daily; Claritin 2.5 mg liquid 1 time daily
Current Illness: Unknown
Preexisting Conditions: Per Maternal Grandmother child has DiGeorge Syndrome
Diagnostic Lab Data: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURU1004AC3IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.J0042010SCLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH080923IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0099870SCRL
Administered by: Private     Purchased by: Public
Symptoms: Rash, Rash papular, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Per Maternal Grandmother large flat patches to face, armpits and trunk started AM on 6/13/14 was taken to PCP, sent home with Claritin. On 6/23/14 Fine papular rash to chest, face and back, went back to PCP where they were told it looks like varicella.

VAERS ID:535394 (history)  Vaccinated:2014-06-16
Age:45.0  Onset:2014-06-16, Days after vaccination: 0
Gender:Male  Submitted:2014-06-30, Days after onset: 14
Location:Washington  Entered:2014-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH139950IMLA
Administered by: Private     Purchased by: Public
Symptoms: Fatigue, Local reaction, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: He apparently had a severe local reaction to his Prevnar vaccine at our last appointment and developed a rash on his back that improved with topical steroids. He also was extremely fatigued for 5 days but is now feeling back to his baseline. I think his symptoms were all due to Prevnar and he will continue to monitor and let us know if he starts feeling different to his baseline.

VAERS ID:535424 (history)  Vaccinated:2014-05-27
Age:0.5  Onset:2014-05-27, Days after vaccination: 0
Gender:Female  Submitted:2014-05-27, Days after onset: 0
Location:Arkansas  Entered:2014-06-30, Days after submission: 34
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None noted
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: AR1414
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4661AA1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH173001IMLL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41CB403A1PO 
Administered by: Public     Purchased by: Private
Symptoms: Crying, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad)
Write-up: 5/27/14 1600 Pt mother called - left message for return call. Nurse called back. Pt had 4 mth old vaccines around 10:00am and has been crying ever since. Mother c/o leg slight swollen. Mother states she has given infant MOTRIN, batch and placed ice pack on leg. Counseled parent per policy. Infant quiet on phone P/T feeding. Advised parent since concerns take to PCP/ER. 5-28-14 0800 TC to pt # left message for return call. 5-29-14 1000 TC to pt # left message - TC x3 no answer.

VAERS ID:535459 (history)  Vaccinated:2014-06-26
Age:66.0  Onset:2014-06-27, Days after vaccination: 1
Gender:Female  Submitted:2014-06-30, Days after onset: 3
Location:Washington  Entered:2014-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRIVA; Albuterol sulfate; ADVAIR; Acyclovir; Ibuprofen; FLEXERIL; PROAIR; NICOTROL
Current Illness: Routine PAP.
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHJ1011740IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS52DM50IMRA
Administered by: Public     Purchased by: Private
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 06/30/14 Pt was seen at the walk-in clinic today, reported red, itchy rash the next evening of the vaccination - bilateral rib area below both breasts, bilateral armpits, underarms, bilateral thigh and groin. Continues to worsen and spread.

VAERS ID:535456 (history)  Vaccinated:2014-06-13
Age:2.0  Onset:2014-06-14, Days after vaccination: 1
Gender:Male  Submitted:2014-06-27, Days after onset: 13
Location:Foreign  Entered:2014-06-30, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: 13-JUN-2014, Body temperature, 36.8 Centigrade
CDC Split Type: 2014170458
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH13J05A SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Feeling hot, Injection site cellulitis, Injection site erythema, Injection site swelling, Joint swelling, Local swelling, Pruritus, Sensation of heaviness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad)
Write-up: This is a spontaneous report received from a contactable physician through regulatory authority under the regulatory authority report number of V14000155. A 32-month-old male patient of an unspecified ethnicity (birth weight: 2610 g) received PREVENAR 13 (Lot #: 13J05A) subcutaneously into the left upper arm at 0.5ml single dose at 16:10 on 13Jun2014. Body temperature before administration on 13Jun2014 was 36.8 degrees C. The patient did not have medical history including family history. The patient''s concomitant medications were not reported. The patient experienced cellulitis of left upper arm and forearm at 09:30 on 14Jun2014. Clinical course was as follows. On 14Jun2014: Swelling of the injection site (left upper arm) developed around 09:30, and it spread to the left forearm afterward. On 15Jun2014 the left arm swelled up to twice the size of the right arm which had not received a vaccination. And it was accompanied by itching, although obvious pain was not observed. Thereafter swelling of the forearm became heavier than upper arm. On 16Jun2014 the patient visited the reporting physician in the morning. Redness and swelling developed mainly at the injection site of the upper arm and swelling throughout the wrist with feeling hot but not with obvious tenderness were observed at the consultation. Cooling especially anterior part of upper arm was instructed. On 18Jun2014 the event was resolving after follow-up observation. Swelling subsided. The forearm returned to normal appearance, but swelling remained in the upper arm. The patient was diagnosed as cellulitis of left upper arm and forearm from the clinical course. The physician classified the event as non-serious and assessed it as related to PREVENAR 13 while denying other factors.

VAERS ID:535463 (history)  Vaccinated:2014-01-24
Age:0.5  Onset:2014-01-24, Days after vaccination: 0
Gender:Unknown  Submitted:2014-06-27, Days after onset: 153
Location:Foreign  Entered:2014-06-30, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Laboratory studies (unknown date): except leucocytosis and relative granulocytosis no alarming symptoms were observed
CDC Split Type: 2014172656
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEURK4120 IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG62163 IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Granulocytosis, Hypotonic-hyporesponsive episode, Leukocytosis, Loss of consciousness, Pyrexia, Syncope, Upper respiratory tract infection, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad)
Write-up: This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number PL-URPL-N209/2014. The physician is contactable to HA only. A 5-month-old patient of an unspecified gender received PREVENAR 13 (lot number G62163, expiration date Mar2015) in right thigh and PENTAXIM (lot number K4120-1, expiration date Apr2015) in the left thigh, both intramuscularly, on 24Jan2014, at 0.5 ml single. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 24Jan2014 at 19.30 the patient experienced fever at 38.0-38.4 Celsius degrees, hypotonic-hyporesponsive episode with loss of consciousness, faint, upper respiratory tract infection, leukocytosis and granulocytosis. Seizures were not observed. All the events required hospitalization (patient admitted on 24Jan2014 at 19:30). Hospitalization lasted 5 days. The patient recovered from all events on unknown date. In the laboratory studies except leucocytosis and relative granulocytosis no alarming symptoms were observed. Previous reaction to vaccination was good. PENTAXIM was the vaccine suspected causing the post vaccinal reaction. The physician has assessed the post vaccinal reaction as benign. The change of the qualification was not changed in agency. There was a time connection between vaccine administration and post vaccinal reaction appearance. The reporter has considered the reaction as benign, however the health authority due to the character of reported symptoms has considered the reaction as serious. The reported adverse reactions are known and expected after given vaccines.

VAERS ID:535464 (history)  Vaccinated:2012-11-22
Age:1.0  Onset:2013-07-01, Days after vaccination: 221
Gender:Female  Submitted:2014-06-27, Days after onset: 361
Location:Foreign  Entered:2014-06-30, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 06-FEB-2012, PREVENAR 13; 20-APR-2012, PREVENAR 13; 06-FEB-2012, DITEKIPOL/ACTHIB; 20-APR-2012, DITEKIPOL/ACTHIB
Diagnostic Lab Data: 03-APR-2014, Skin test positive, Aluminum allergy
CDC Split Type: 2014173821
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPPHIB: DTP + IPV + ACT-HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 2UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergy to metals, Pruritus, Rash pruritic, Skin irritation, Skin test positive, Vaccination site granuloma
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This is a spontaneous report from a contactable physician received from the foreign regulatory authority. Regulatory authority report number DK-DKMA-ADR 22582480 and DK-DKMA-EFO9272. A 20 months old female patient of an unspecified ethnicity received PREVENAR 13 via an unspecified route of administration on 22Nov2012 at 12 months, 0.5ml single dose and DITEKIPOL/ACTHIB via an unspecified route of administration on 22Nov2012 at 1 DF, single. The patient received previously dose of both vaccine on 06Feb2012 at 2 months and on 20Apr2012 at 5 months. The patient medical history was not reported. The patient''s concomitant medications were reported as noen. The patient experienced aluminum allergy on an unspecified date with outcome of not recovered, vaccination granuloma/itching deep-lying granuloma on 01Jul2013 with outcome of recovering, itchy rash on right thigh on 01Jul2013 with outcome of recovering, daily irritation in the area of the thigh, on 01Jul2013 with outcome of recovering. The patient was treated with antihistamine, but this did not have any effect. Local steroid treatment given under occlusion had some effect. The patient underwent lab tests and procedures which included skin test positive: aluminum allergy on 03Apr2014.

VAERS ID:535471 (history)  Vaccinated:0000-00-00
Age:0.2  Onset:0000-00-00
Gender:Female  Submitted:2014-06-27
Location:Foreign  Entered:2014-06-30, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2014171297
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEUR  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Discomfort, Emotional distress, Erythema, Irritability, Local swelling, Mood altered, Screaming, Somnolence
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad)
Write-up: This is a spontaneous report from a physician via the contactable regulatory authority. Regulatory Authority report number: ADR GB-MHRA-ADR 22577207. A 2 months old female patient, received PREVENAR 13 and also PEDIACEL at an unknown dose, on an unknown date, both via parenteral route. The patient''s medical history was not reported. Concomitant medication was not reported. On an unknown date the reporter reported that the patient was overly sleepy and irritable; saw the doctor who checked the baby and prescribed paracetamol. Baby had swollen red legs and screamed inconsolably, then became sleepy and remained sleepy. She was grumpy when awake and seemed uncomfortable. The action taken vaccines in response to the events was not applicable. The patient had not recovered from the events of being irritable and sleepy at the time of this report. The outcome for the events of redness of legs, swelling of legs, screaming and discomfort were unknown. The reporter considered the case to be serious as the events were medically significant and the regulatory authority considered the case to be serious for an unspecified reason.

VAERS ID:535495 (history)  Vaccinated:2013-05-07
Age:0.4  Onset:2013-05-07, Days after vaccination: 0
Gender:Unknown  Submitted:2014-06-30, Days after onset: 419
Location:Foreign  Entered:2014-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1406POL013115
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB515A IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Other     Purchased by: Other
Symptoms: Anxiety, Crying, Decreased appetite
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: This spontaneous report as received from a physician via the Agency (agency # PL-URPL-N629/2013) on 25-JUN-2014, refers to a 4 month old patient. On 07-MAY-2013, the patient was vaccinated with a dose of ROTATEQ, oral. Other suspect therapies included vaccination with a dose of INFANRIX HEXA on 07-MAY-2013, 0.5ml, IM in the right thigh, batch number A21CB515A, expiration date September 2014). Concomitant therapies included vaccination with a dose of PREVENAR 13 on 07-MAY-2014, IM in the left thigh. On 07-MAY-2013, the patient experienced persistent crying, appetite suppression and anxiety and was hospitalized (date unspecified in approximately 2013). The outcome of persistent crying, appetite suppression and anxiety was reported as recovered/resolved. Persistent crying, appetite suppression and anxiety were considered related to INFANRIX HEXA. The relatedness between events and ROTATEQ was not reported. Additional information is not expected.

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